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Drawing up a PGD for Hib immunisation

A new national campaign aims to cut the number of cases of Haemophilus influenzae infection. Jane Chiodini explains how to set up a PGD for Hib vaccination

Infections caused by Haemophilus influenzae can result in serious morbidity. Invasive disease is usually caused by encapsulated strains of the bacterium; six capsular serotypes (a-f) cause disease in humans, and over 99% of typable strains causing invasive disease are type b (Hib).1

The most common presentation of invasive Hib disease is meningitis, accompanied by bacteraemia in approximately 60% of cases. However, it can also cause other diseases (Table 1, below).2

Table 1: Invasive diseases caused by Haemophilus influenzae type b

Disease

Symptoms

Serious complications

Meningitis

Fever, refusing to feed, irritable/high-pitched cry in babies, pale or blotchy skin, difficult to wake, stiff body with jerky movements or else floppy and listless, tense or bulging soft spot on the head

15-30 children in every 100 will develop long-term problems, such as: Hearing disorders Learning and language disability or delayed development Seizures Visual impairment One child in every 20 who develop Hib meningitis will die

Epiglottitis

Swelling of the epiglottis, causing noisy and painful breathing

Severe blockage of the airway which can be fatal

Septic arthritis

Fever, painful, red, hot and swollen joints

Permanent damage to joints Septicaemia

Osteomyelitis

Fever, painful limbs

Long-term bone infection Septicaemia

Cellulitis

Sore, hot painful area of skin

Septicaemia

Pneumonia

Cough, breathing difficulties, chest pain

Septicaemia Can cause death

Pericarditis

Chest pain, breathing difficulties

Can cause death

Hib was introduced into the routine immunisation programme in 1992, along with a catch-up programme for all children aged between 6 months and 4 years of age. It resulted in very successful control of the disease; by 1998, laboratory confirmed cases of Hib in children under 5 years of age had fallen by 98%.

However, since that time, better surveillance of Hib disease has shown a rise in the number of cases, mostly in children under 4 years of age.3 As a result, the Joint Committee on Vaccination and Immunisation has advised that immunity needs to be further enhanced, and an additional dose of Hib should be offered to all children under 4 years of age.3

A Department of Health vaccination campaign began on 12 May 2003 and will run for 4 months so as to be completed just before the influenza vaccination season.4 The following groups should be offered an extra dose of Hib vaccine:

All children who will be aged over 6 months and under 4 years on 1 April 2003 (i.e. born between 2 April 1999 and 1 October 2002).

Babies reaching 6 months of age from 1 April 2003 until the end of the campaign (i.e. those born between 1 October 2002 and 12 March 2003).

Full details of the implementation of the campaign were given in a letter dated 10 April from the DoH to all surgeries and can be viewed on the DoH website.4 Promotional materials were also sent to surgeries in the same month, together with information on how to obtain further leaflets and posters.

Setting up a patient group direction

Patient group directions (PGDs) have been a legal requirement within the NHS sector throughout the UK since 9 August 2000. National guidance is now available in England,5 Wales6 and Scotland.7

PGDs should be in place for the administration of these prescription-only medicines to groups of patients who may not be individually identified before presentation at the surgery.

Nurses administering these vaccines must therefore only do so if there is an appropriate PGD in place. To do otherwise would be to act illegally and could result in a criminal prosecution under the Medicines Act.5,6,7 It is now more than 2 years since the change in the law and imperative that such documents are in place.

To work in accordance with a PGD, the nurse administering the POM must be named within the document and must sign it, as must the senior doctor in the practice, giving his/her authorisation for the nurse to work within the PGD.

Before signing, the doctor must be satisfied that the nurse has sufficient knowledge and is competent to administer the immunisation in line with the Nursing and Midwifery Council (NMC) Professional Code of Conduct8 and NMC Standards for the Administration of Medicines.9

It is useful to gather together all the information you need before starting work on a PGD, and it is essential to have access to the summary of product characteristics (SPCs) for the vaccines. SPCs are available directly from the drug manufacturers and on the internet at http://emc.vhn.net/.

The PGD should include:

The name of the business to which the direction applies

The date the direction comes into force and the date it expires

A description of the medicine(s) to which the direction applies

Class of health professional who may supply or administer the vaccine

Signature of a senior doctor or dentist and a pharmacist

Signature of an appropriate health organisation

The clinical condition or situation to which the direction applies

A description of those patients excluded from treatment under the direction

A description of the circumstances in which further advice should be sought from a doctor (or dentist, as appropriate) and arrangements for referral

Details of the appropriate dosage and maximum total dosage, quantity, pharmaceutical form and strength, route and frequency of administration and minimum or maximum period over which the medicine should be administered

Relevant warnings including potential side-effects

Details of any necessary follow up action and the circumstances

A statement of the records to be kept for audit purposes.

The PGD for Hib vaccine is generic and must be adapted to take account of local needs and the particular product being used.

If the DoH campaign is implemented successfully, there should be a significant and rapid reduction in Hib cases and the low rate of Hib disease will be maintained.

The DoH is considering whether there is a need to change the routine childhood immunisation schedule for Hib and other vaccines. Scientific and medical evidence is being assessed and information will be given in due course.4

The National Welsh Assembly. Review of prescribing, supply and administration of medicines – sale, supply and administration of medicines by health professionals under patient group directions (PGD). COCNOCDOC SOCPhA-SALEMED3. 22 December 2000.